Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT02504320
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Set included all participants who received at least 1 dose of study drug.
Frequency Threshold: 0
Time Frame: From the first administration of study drug on Day 1 of Period 1 up to 30 days after the last dose of study drug or Early termination visit (approximately up to 95 days)
Study: NCT02504320
Study Brief: Phase 1, Febuxostat XR Relative Bioavailability Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regimen A: Febuxostat XR 80 mg Formulation 1 Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4. None None 0 76 6 76 View
Regimen B: Febuxostat XR 80 mg Formulation 2 Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4. None None 1 76 9 76 View
Regimen C: Febuxostat XR 80 mg Formulation 3 Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4. None None 0 77 7 77 View
Regimen D: Febuxostat XR 80 mg Formulation 4 Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4. None None 0 76 7 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 18.0 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 18.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 18.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.0 View
Bacterial vaginosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.0 View
Trichomoniasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 18.0 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 18.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 18.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.0 View
Papule SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 18.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 18.0 View